Evidence map›Paper›PMID 22776413›Full record

Trial reportCell transplantation2013

Stem cell therapy for craniofacial bone regeneration: a randomized, controlled feasibility trial.

Darnell Kaigler, Giorgio Pagni, Chan Ho Park, Thomas M Braun, Lindsay A Holman, Erica Yi, Susan A Tarle, Ronnda L Bartel, William V Giannobile

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cell transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 91 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 8 pooled it
12.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 8 syntheses or guidelines pooled it, 187 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review

31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Darnell KaiglerDepartment of Periodontics and Oral Medicine, University of Michigan, Ann Arbor, MI, USA. dkaigler@umich.edu
Giorgio Pagni
Chan Ho Park
Thomas M Braun
Lindsay A Holman
Erica Yi
Susan A Tarle
Ronnda L Bartel
William V Giannobile
University of Michigan–Ann Arbor · USAastrom Biosciences (United States) · US

Funding

MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
GENE THERAPY FOR RECONSTRUCTING PERIODONTAL TISSUESR01DE013397 · NIDCR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GIANNOBILE, WILLIAM V · 2000 to 2014
$4.0M
NCRR NIH HHS UL1 RR024986NCRR NIH HHS UL1RR024986NIDCR NIH HHS DE13397NIDCR NIH HHS R01 DE013397
6 · The paper itself

Abstract

Stem cell therapy offers potential in the regeneration of craniofacial bone defects; however, it has not been studied clinically. Tissue repair cells (TRCs) isolated from bone marrow represent a mixed stem and progenitor population enriched in CD90- and CD14-positive cells. In this phase I/II, randomized, controlled feasibility trial, we investigated TRC cell therapy to reconstruct localized craniofacial bone defects. Twenty-four patients requiring localized reconstruction of jawbone defects participated in this longitudinal trial. For regenerative therapy, patients were randomized to receive either guided bone regeneration (GBR) or TRC transplantation. At 6 or 12 weeks following treatment, clinical and radiographic assessments of bone repair were performed. Bone biopsies were harvested and underwent quantitative micro-computed tomographic (μCT) and bone histomorphometric analyses. Oral implants were installed, subsequently restored, and functionally loaded with tooth restorations. Reconstructed sites were assessed for 1 year following therapy. No study-related, serious adverse events were reported. Following therapy, clinical, radiographic, tomographic, and histological measures demonstrated that TRC therapy accelerated alveolar bone regeneration compared to GBR therapy. Additionally, TRC treatment significantly reduced the need for secondary bone grafting at the time of oral implant placement with a five fold decrease in implant bony dehiscence exposure (residual bone defects) as compared to GBR-treated sites(p < 0.01). Transplantation of TRCs for treatment of alveolar bone defects appears safe and accelerates bone regeneration, enabling jawbone reconstruction with oral implants. The results from this trial support expanded studies of TRC therapy in the treatment of craniofacial deformities (ClinicalTrials.gov number CT00755911).

Indexed as

Bone RegenerationStem Cell TransplantationAdultAgedBone DensityBone Marrow CellsFemaleGuided Tissue Regeneration, PeriodontalHistocompatibilityHumansJawLipopolysaccharide ReceptorsLongitudinal StudiesMaleMesenchymal Stem CellsMiddle AgedLipopolysaccharide ReceptorsThy-1 Antigens

Identifiers

PMID22776413
PMCPMC4100608
OpenAlexW2101906967

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.